FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics
pharmafile | December 11, 2018 | News story | Manufacturing and Production, Sales and Marketing | FDA, Novartis, Pear Therapeutics, app, opioid crisis, opioid epidemic, opioids, pharma, reSET-o
A digital therapeutic launched by Pear Therapeutics and Novartis’ generics and biosimilars division Sandoz has become the first FDA-approved app of its kind for use in the treatment of opioid use disorder (OUD), it has emerged.
reSET-O is a prescription mobile device application which is intended to be used as part of an outpatient OUD treatment programme. It delivers cognitive behavioural therapy (CBT) over 12 weeks to patients alongside outpatient treatment which includes ransmucosal buprenorphine (medication-assisted-treatment, or MAT) and contingency management in adult patients under the supervision of a clinician.
The app’s approval was supported by data derived from a trial of 170 participants over the 12-week use period. It was found that reSET-O significantly improved retention rates and reduced patient dropouts when used in combination with treatment-as-usual of clinician interaction and buprenorphine, compared to treatment-as-usual alone.
“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” commented Richard Francis, CEO at Sandoz. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes. At Sandoz, we are proud to be a joint pioneer in this exciting new field.”
Corey McCann, President and CEO of Pear Therapeutics, also added: “Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the US in 2017. There is an urgent need for new and innovative therapeutics to address this public health epidemic. This ground-breaking decision by the FDA ushers in a new standard for treating patients with opioid use disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.”
Under the terms of the partnership between the two manufacturers, Sandoz will handle marketing and commercialisation of the product, with a launch planned in the coming days.
Matt Fellows
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